Turn regulatory requirements intoa structured market-access process
CSA supports medical device manufacturers with MDR compliance, regulatory documentation, EU representation and EUDAMED readiness.
Know what is ready, what is missing and what comes next.
Our approach separates manufacturer responsibilities, representation tasks and documentation requirements into clear regulatory workstreams.
Start with the gap, not with the paperwork
Effective compliance work begins by understanding your device, regulatory status and existing evidence.
Define scope
Manufacturer, device, intended purpose, classification and target market.
Review evidence
Identify existing documentation and missing regulatory elements.
Close gaps
Organise actions into a controlled compliance workstream.
Maintain compliance
Keep documentation, registrations and post-market processes current.
Practical support across the EU medical device lifecycle
MDR Compliance Review
Structured review of regulatory status, classification, documentation and readiness for EU market access.
Explore MDR compliance →EU Authorised Representation
Support for manufacturers established outside the European Union requiring an EU-based regulatory representative.
EU representation →Technical Documentation
Organise the regulatory evidence expected under the MDR into a clear and reviewable technical documentation structure.
Technical documentation →EUDAMED Readiness
Prepare actor, UDI and device information for the mandatory EUDAMED environment.
EUDAMED →Verify Certificates
Check a CS Active-issued document by its exact certificate number or the full company name.
Verify a certificate →Compliance is a maintained system, not a one-time certificate
MDR obligations continue after market entry through documentation, post-market surveillance, vigilance processes and regulatory updates.
- Device classification and intended purpose
- Technical documentation structure
- Declaration and conformity evidence
- Labelling and identification
- EUDAMED data readiness
- Post-market surveillance documentation
Mandatory registration changes how regulatory data is managed
Actor Registration and UDI/Device Registration became mandatory EUDAMED modules from 28 May 2026.
Prepare for EUDAMED →Legal entity data, actor information, UDI identifiers and device attributes need to remain consistent across documentation, registrations and market-facing information.
Common compliance questions
Can CSA certify a medical device?
Where conformity assessment by a Notified Body is required, certification must be performed by an appropriately designated Notified Body. CSA provides regulatory and compliance support and does not present itself as a Notified Body.
Does a non-EU manufacturer require an EU representative?
Under the MDR, manufacturers not established in an EU Member State generally require a sole Authorised Representative for covered devices placed on the Union market.
Is technical documentation required for Class I devices?
Yes. Class I status does not remove the manufacturer's MDR technical-documentation obligations.
Is EUDAMED mandatory?
The Actor Registration and UDI/Device Registration modules, together with two other modules, became mandatory on 28 May 2026.
Need a clear view of your regulatory gaps?
Start with your manufacturer details and device portfolio.